Randomized Phase I Trial of Two Different Combination Foscarnet and Ganciclovir Chronic Maintenance Therapy Regimens for AIDS Patients with Cytomegalovirus Retinitis: AIDS Clinical Trials Group Protocol 151

Mark A. Jacobson, Francoise Kramer, Yiannis Bassiakos, Thomas Hooton, Bruce Polsky, Heidi Geheb, James J. O'Donnell, John D. Walker, Joyce A. Korvick, Charles Van Der Horst

Research output: Contribution to journalArticle

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Abstract

AIDS patients with newly diagnosed cytomegalovirus (CMV) retinitis who had just completed a 14-day course of ganciclovir induction therapy were randomly assigned to an alternating or concurrent combination regimen of chronic ganciclovir-foscarnet therapy for CMV retinitis. Each regimen used lower weekly cumulative doses of each drug than standard monotherapy maintenance treatment regimens. Dose-limiting toxicity attributable to foscarnet occurred in only 2 (7%) of 29 evaluatable patients, and no patients experienced dose-limiting nephrotoxicity. Although absolute neutrophil counts <500 cells/μL occurred in 11 (38%) of 29 patients, all who subsequently used adjunctive granulocyte colony-stimulating factor had severe neutropenia prevented. Severe toxicity of any type and neutropenia, in particular, occurred significantly more frequently in patients assigned to the concurrent treatment regimen. CMV was isolated from none of 21 patients who had urine cultured and from only 1 of 24 who had blood cultured while being treated during the study (median evaluation, 12 weeks). This suggests that combination therapy provides better in vivo antiviral activity in suppressing CMV replication than previously reported with monotherapy regimens.

Original languageEnglish
Pages (from-to)189-193
Number of pages5
JournalJournal of Infectious Diseases
Volume170
Issue number1
StatePublished - Jul 1 1994
Externally publishedYes

Fingerprint

Cytomegalovirus Retinitis
Foscarnet
Ganciclovir
Clinical Protocols
Acquired Immunodeficiency Syndrome
Clinical Trials
Neutropenia
Cytomegalovirus
Therapeutics
Granulocyte Colony-Stimulating Factor
Antiviral Agents
Neutrophils
Urine
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Immunology
  • Public Health, Environmental and Occupational Health

Cite this

Randomized Phase I Trial of Two Different Combination Foscarnet and Ganciclovir Chronic Maintenance Therapy Regimens for AIDS Patients with Cytomegalovirus Retinitis : AIDS Clinical Trials Group Protocol 151. / Jacobson, Mark A.; Kramer, Francoise; Bassiakos, Yiannis; Hooton, Thomas; Polsky, Bruce; Geheb, Heidi; O'Donnell, James J.; Walker, John D.; Korvick, Joyce A.; Van Der Horst, Charles.

In: Journal of Infectious Diseases, Vol. 170, No. 1, 01.07.1994, p. 189-193.

Research output: Contribution to journalArticle

Jacobson, Mark A. ; Kramer, Francoise ; Bassiakos, Yiannis ; Hooton, Thomas ; Polsky, Bruce ; Geheb, Heidi ; O'Donnell, James J. ; Walker, John D. ; Korvick, Joyce A. ; Van Der Horst, Charles. / Randomized Phase I Trial of Two Different Combination Foscarnet and Ganciclovir Chronic Maintenance Therapy Regimens for AIDS Patients with Cytomegalovirus Retinitis : AIDS Clinical Trials Group Protocol 151. In: Journal of Infectious Diseases. 1994 ; Vol. 170, No. 1. pp. 189-193.
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